Duns Number:078352849
Device Description: A device designed to be used during the planning and post-osteotomy stages of a dental imp A device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure. Osteotomy Depth Gauge - Markings at 8,10,12,14, and 17mm
Catalog Number
Depth Gauge
Brand Name
DDP Depth Gauge
Version/Model Number
Depth Gauge
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIL
Product Code Name
Gauge, Depth, Instrument, Dental
Public Device Record Key
f94ea198-51ef-4cb3-af4b-cb0894c6b89d
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |